1. The Field of the Invention
Exemplary embodiments of the present invention relate to the field of catheters, and, more particularly, to a self-suturing anchor device for use with a catheter.
2. Background and Relevant Art
Catheters play an important role in the treatment and care of patients in modern medicine. In particular, catheters provide relatively unobtrusive access to remote portions of a patient's body, allowing desired procedures or treatments to be performed.
A wide variety of generalized and specialized catheters have been developed and refined for particular uses. For example, angioplasty catheters have been adapted to provide a safe and effective conduit for the delivery of a stent and/or balloon to a narrowing or blockage in a patient's artery or vein. Drainage catheters are configured to be inserted into a cavity surrounding a patient's kidney, liver or other organ to drain excess fluid or infection from the cavity.
In addition, a number of devices and implements have been developed for use with catheters, to facilitate their effectiveness, or to overcome inherent difficulties associated with their use. For example, catheters that are designed to remain placed in a patient for long periods of time, such as for ongoing care or treatment of the patient, present a number of difficulties. Such catheters must be secured to the patient in a manner that minimizes movement of the catheter that could harm the patient, or otherwise interrupt proper functioning of the catheter.
Accordingly, one approach in the prior art has been to suture the catheter directly to the patient's skin. However, when a patient repositions himself/herself in bed, the catheter may pull at the suture site or bend the catheter. Another approach is to inflate a balloon associated with the distal end of the catheter inside the patient. However, at times an incoherent patient may attempt to withdraw or otherwise remove the catheter. This can cause injury to the catheter insertion site, or can interfere with proper operation of the catheter.
In view of these and other problems in the art, a number of devices have been developed to secure a catheter in a manner that minimizes movement of the catheter, or minimizes interference with its proper operation. Typically, such devices include an adhesive layer to be secured to the patient with a small bore for accommodating the catheter and an adhesive strip to secure the catheter relative to the adhesive layer. Devices such as these are useful because they can be employed by a practitioner to secure the desired positioning of the catheter. Such devices, however, can be undesirable due at least in part to the fact that they typically obstruct the catheter insertion site. This can make it difficult to identify infections, drainage, or other complications that may occur at the catheter insertion site. Furthermore, the devices can also obstruct cleaning of the insertion site, such that the site can only be cleaned by removing the anchor devices. Additionally, conventional anchor devices typically utilize a clip, or other securement member which typically is rigid or has a high profile when utilized to secure the catheter. As a result, the securement device can be uncomfortable if pressed against the patient by a chair, bed, or other object.
FIG. 1 illustrates a modified version of an anchor device 10 that has been conventionally utilized by practitioners to secure a catheter. Anchor device 10 comprises a stoma covering that is modified by a practitioner to secure a catheter. Such stoma coverings are typically used to secure a drainage bag, such as a colostomy, illeostomy, or other similar such ostomy bag. Anchor device 10 includes an adhesive sheet 12, a semi-rigid ring 14, a sealing layer 16, and a center aperture 18. Adhesive sheet 12 provides a mechanism for securing anchor device 10 to a patient.
Adhesive sheet 12 also secures semi-rigid ring 14 in a desired position relative to the stoma, catheter, or article or apparatus to be secured to the patient. Semi-rigid ring 14 facilitates securing of a catheter, drainage bag, or other article or apparatus. Sealing layer 16 is positioned beneath and radially inward from semi-rigid ring 14, and covers a substantial portion of the bottom surface of anchor device 10. The inner boundary of sealing layer 16 defines center aperture 18. Sealing layer 16 provides a fluid tight seal with the patient to minimize leakage of bodily fluids outside of center aperture 18. Sealing layer 16 is somewhat resilient, or otherwise deformable, to thereby conform anchor device 10 to the patient's body around the stoma. Sealing layer 16 can include adhesive properties to maintain sealing contact with the patient.
The illustrated stoma covering also includes an adhesive backing (not shown) provided on the back side of sealing layer 16, and another adhesive backing (not shown) provided on the back side of adhesive sheet 12. The practitioner removes the adhesive backing from sealing layer 16 and adhesive sheet 12, and thereafter positions anchor device 10 on the patient's skin so that catheter 22 is within center aperture 18.
A practitioner modifies the conventional stoma covering by first removing the portion of sealing layer 16 that is positioned radially inward from semi-rigid ring 14. The portion of sealing layer 16 positioned radially inward from semi-rigid ring 14 can be removed utilizing a scalpel, scissors, or other implement. The practitioner then threads a first suture 24 from a right side 34 of semi-rigid ring 14 to a securement point 28 on catheter 22, and wraps first suture 24 around catheter 22 utilizing a first double-wrapped suture configuration 38. The practitioner then threads first suture 24 from catheter 22 to a left side 32 of semi-rigid ring 14, and then once again back to catheter 22. The practitioner then uses another double-wrapped suture configuration 40 to secure first suture 24 to catheter 22, such that the two double-wrapped suture configurations 38 and 40 define securement point 28. The second end of suture 24 is then threaded to right side 34 of semi-rigid ring 14, and tied to the first end of suture 24.
Once the practitioner has affixed suture 24 to securement point 28, the practitioner then secures catheter 22 to the bottom of semi-rigid ring 14 by first securing second suture 26 to catheter 22 adjacent bottom 36 of semi-rigid ring 14 on one side of semi-rigid ring 14. The practitioner then threads second suture 26 through the wall of semi-rigid ring 14 to an opposing side of semi-rigid ring 14. Second suture 26 is then secured to catheter 22 on the opposing side of semi-rigid ring 14. Done in this manner, catheter 22 is directly secured on both opposing surfaces of bottom 36 of semi-rigid ring 14 such that movement of the portion of catheter 22 associated with second securement point 30 is minimized.
One will appreciate, therefore, that sutures 24 and 26 can provide more stability and control of catheter 22 than would otherwise be provided by a single suture. For example, first suture 24 anchors catheter 22 to both left side 32 and to right side 34 of semi-rigid ring 14 to provide lateral stability to catheter 22 relative to a catheter insertion site. Furthermore, second suture 26 minimizes movement of the portion of catheter 22 associated with second securement point 30, such that catheter 22 does not pivot relative to securement point 28 in a manner that could result in lateral forces, pressure and/or tearing at the catheter insertion site. In addition, this arrangement allows access to the catheter insertion site and the inner boundary of semi-rigid ring 14 without obstruction. Such access allows a practitioner to identify and/or care for potential problems without needing to remove or reposition the anchor device 10.
While anchor device 10 provides advantages over other catheter securement devices, anchor device 10 presents a number of disadvantages in operation. For example, anchor device 10 is modified after the catheter is inserted into the patient. The time required to modify the anchor device and subsequently secure the catheter can add a significant amount of time to the catheter insertion procedure (e.g., 10-15 minutes or more). This can be uncomfortable for the patient in routine procedures. In more complex surgical procedures this can interfere with other aspects of the procedure to be performed, thus increasing the time the patient is under anesthesia. Additionally, the cost of the surgery is increased due to increased operating room and personnel time.